ANDA 091289

ACTAVIS LABS FL INC

FDA Drug Application

Application #091289

Documents

• Letter: 2012-10-15

Application Sponsors

ANDA 091289

ACTAVIS LABS FL INC

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE, EXTENDED RELEASE;ORAL

60MG

0

TROSPIUM CHLORIDE

TROSPIUM CHLORIDE

FDA Submissions

ORIG

1

AP

2012-10-12

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

ACTAVIS LABS FL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91289
            [companyName] => ACTAVIS LABS FL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"TROSPIUM CHLORIDE","activeIngredients":"TROSPIUM CHLORIDE","strength":"60MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TROSPIUM CHLORIDE","submission":"TROSPIUM CHLORIDE","actionType":"60MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)